Patient eligibility for application of a two-filter cerebral embolic protection device during transcatheter aortic valve implantation: Does one size fit all?

Abstract

OBJECTIVES: This study sought to determine the percentage of patients potentially eligible for implantation of the SentinelTM Cerebral Protection System (Sentinel-CPS) during transcatheter aortic valve implantation (TAVI) and to identify the reasons for treatment exclusion. METHODS: We retrospectively performed an analysis of pre-TAVI multislice computed tomography (MSCT) aortograms and data review of all patients undergoing a TAVI procedure in 2017 (n = 317). MSCT evaluation included the assessment of aortic arch anatomy and the vascular dimensions of the brachiocephalic and left common carotid artery. Data analysis focused on comorbid conditions, precluding 6-Fr sheath radial access and filter deployment due to history of previous artery interventions. RESULTS: MSCT and data analysis showed Sentinel-CPS compatibility in 61.5% of patients (n = 195). Sentinel-CPS would have been contraindicated in 38.5% (n = 122) due to one or more of the following: (i) measured diameters of the filter-landing zones <9 or >15 mm in the brachiocephalic artery and <6.5 or >10 mm in the left common carotid artery (n = 116; 88 with carotid dimensions too small); (ii) significant subclavian artery stenosis (n = 4) or an aberrant subclavian artery (n = 3) precluding Sentinel-CPS implantation and (iii) clinical characteristics including hypersensitivity to nickel-titanium (n = 1), radial artery occlusion (n = 1) or previous left common carotid artery interventions (n = 5). CONCLUSIONS: MSCT and clinical data supported Sentinel-CPS compatibility in 61.5% of patients. The most common reason for treatment exclusion was inappropriate diameter within the target landing zone of the left carotid artery. Future device development should address this limitation.